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Adcetris(Brentuximab Vedotin), IIB, IIIB 및 IV기 Hodgkin 림프종을 앓고 있는 젊은 환자를 치료하기 위한 병용 화학 요법 및 방사선 요법

2026년 11월 11일 업데이트: St. Jude Children's Research Hospital

Adcetris(Brentuximab Vedotin), OEPA/COPDac 요법[Euro-Net C1의 치료군 3(TG3)]에서 Vincristine을 고위험 소아 Hodgkin 림프종(HL) 관련 림프절 방사선 요법으로 대체

This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Drugs used in chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving brentuximab vedotin with combination chemotherapy may kill more cancer cells and reduce the need for radiation therapy.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

PRIMARY OBJECTIVES:

  • To evaluate the safety of brentuximab vedotin, etoposide, prednisone and doxorubicin hydrochloride (AEPA)/cyclophosphamide, brentuximab vedotin, prednisone and dacarbazine (CAPDac), as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high risk patients with Hodgkin lymphoma (HL).
  • To compare the event-free survival in high risk HL patients treated with AEPA/CAPDac to the historical control unfavorable risk 2 arm (UR2) of the St. Jude HOD99 study.

SECONDARY OBJECTIVES:

  • To estimate the number of patients with adequate response according to the definitions in the Euro-Net C1 after 2 cycles of AEPA.
  • To evaluate the safety of Adcetris (brentuximab vedotin) in the AEPA/CAPDac regimen in children with high risk HL.
  • To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
  • To study the association between local failure and original lymph node region and volume of radiation (patterns of treatment failure).
  • To assess patient-reported symptoms and health-related quality of life in children with high risk HL compared to those treated on the unfavorable treatment arm of the St. Jude HOD99 study.

OUTLINE:

AEPA REGIMEN: Patients receive brentuximab vedotin on days 1, 8, and 15, etoposide on days 1 to 5, prednisone three times daily (TID) on days 1 to 15, and doxorubicin hydrochloride on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.

CAPDac REGIMEN: Patients receive cyclophosphamide on days 1 and 8, brentuximab vedotin days 1 and 8, prednisone TID on days 1 to 15, and dacarbazine on days 1 to 3. Treatment repeats every 21-28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Beginning 2-3 weeks after CAPDac chemotherapy, patients with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy undergo radiation therapy daily, 5 days a week for 3-4 weeks.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

연구 유형

중재적

등록 (실제)

77

단계

  • 2 단계

연락처 및 위치

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연구 장소

  • 미국
    • California
      • Palo Alto, California, 미국, 94304
        • Lucile Packard Children's Hospital Stanford University
    • Illinois
      • Peoria, Illinois, 미국, 61637
        • St. Jude Midwest Affiliate
    • Maine
      • Scarborough, Maine, 미국, 04704
        • Maine Children's Cancer Program (MCCP)
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, 미국, 02115
        • Dana-Farber Harvard Cancer Center
    • Tennessee
      • Memphis, Tennessee, 미국, 38105
        • St. Jude Children's Research Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이하 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Histologically confirmed, previously untreated CD30+ classical Hodgkin Lymphoma (HL). (Participants receiving limited emergent radiation therapy (RT) or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment).
  • Age ≤ 18 years at the time of diagnosis (i.e., participants are eligible until their 19th birthday).
  • Ann Arbor stage IIB, IIIB, IVA, or IVB.
  • Adequate renal function based on GFR ≥ 70 ml/min/1.73m^2 or serum creatinine adjusted for age and gender.
  • Adequate hepatic function (total bilirubin < 1.5 x ULN for age, and SGOT/SGPT < 2.5 x ULN for age).
  • Female participant who is post-menarchal must have a negative urine or serum pregnancy test.
  • Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.

Exclusion Criteria:

  • CD30 negative HL.
  • Has received prior therapy for Hodgkin lymphoma, except as noted above.
  • Inadequate organ function as described above.
  • Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Treatment

Participants receive AEPA regimen (brentuximab vedotin, etoposide, prednisone, doxorubicin), and CAPDac regimen (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine(R)). Filgrastim may be given as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. Some participants may volunteer to complete the quality of life assessment.
의약품: brentuximab vedotin

Given intravenously (IV).

다른 이름들:
  • SGN-35
  • 애드세트리스(R)
의약품: etoposide

Given IV.

다른 이름들:
  • VP-16
  • 베페시드(R)
의약품: prednisone

Given orally (PO).

다른 이름들:
  • 프레드니솔론
의약품: doxorubicin

Given IV.

다른 이름들:
  • 아드리아마이신(R)
의약품: cyclophosphamide

Given IV.

다른 이름들:
  • 사이톡산(R)
의약품: Dacarbazine(R)

Given IV.

다른 이름들:
  • 디메틸 트리아제노 이미다졸 카르복시미드(DTIC)
의약품: filgrastim

Given subcutaneously (SQ) as clinically indicated.

다른 이름들:
  • 뉴포젠(R)
다른: quality of life assessment

Quality of life assessment will be done at initial clinical visit, and during chemotherapy, completion of therapy, then at 1 year, 2 years and 5 years. It should take no more than 15-20 minutes to complete. Participation is voluntary by participating institution and by participant.

방사능: radiation therapy

At the end of chemotherapy and recovery of blood counts, radiotherapy will be given to any involved nodes (if any) that are not in complete remission.

다른 이름들:
  • 조사
  • 방사능
  • 방사선 요법

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
기간: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)

To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.
After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
기간: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)

To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.
After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Complete Response Rate Estimate for All Evaluable Participants
기간: After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)

To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL).
After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)
Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).
기간: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)

Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2).
From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)

2차 결과 측정

결과 측정
측정값 설명
기간
Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac.
기간: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)

The local failure rate within the high-risk HL participants treated with AEPA/CAPDac will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).
From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
Descriptive of Hematological Adverse Events
기간: From enrollment to end of therapy (approximately 8 months)

To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
From enrollment to end of therapy (approximately 8 months)
Descriptive of Infectious Adverse Events
기간: From enrollment to end of therapy (approximately 8 months)

To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
From enrollment to end of therapy (approximately 8 months)
Descriptive of Neuropathic Adverse Events
기간: From enrollment to end of therapy (approximately 8 months)

To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
From enrollment to end of therapy (approximately 8 months)
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0)
기간: At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)

Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 3. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0)
기간: At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)

Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 4. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)
Response Rate
기간: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)

Response compared to the Euro-Net C1 after 2 cycles of AEPA.
after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Patient Quality of Life (QoL)
기간: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment).

Patient QOL will be measured at multiple time points to assess the patient's physical emotional, social, and school functioning.

The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment).
Parent Proxy Quality of Life (QoL)
기간: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)

Parent's assessment of child's physical, emotional, social and school functioning over multiple time points.

The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points
기간: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)

The correlation of agreement between patient and parent Quality of Life is calculated by using the Pearson's Correlation Coefficient, which considers only the record with both parent and patient data.

The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

St. Jude Children's Research Hospital

협력자

Seagen Inc.

수사관

  • 수석 연구원: Matt Ehrhardt, MD, St. Jude Children's Research Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2013년 8월 12일

기본 완료 (실제)

2020년 11월 16일

연구 완료 (추정된)

2028년 5월 1일

연구 등록 날짜

최초 제출

2013년 8월 6일

QC 기준을 충족하는 최초 제출

2013년 8월 8일

처음 게시됨 (추정된)

2013년 8월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 11일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HLHR13
  • NCI-2013-01123 (레지스트리 식별자: NCI Clinical Trial Registration Program)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다